Volcano nets FDA clearance for IVUS catheter, adds distributor

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The FDA has granted clearance for the marketing of the Eagle Eye Platinum digital intravascular ultrasound (IVUS) catheter in the U.S. by intravascular systems developer, Volcano.

The Eagle Eye Platinum-part of the third generation of catheters in the Eagle Eye product line offers plug-and-play functionality as well as grayscale IVUS, virtual histology and ChromaFlo imaging modalities.

The device is slated to be released commercially in the second quarter of 2010, said the San Diego-based company.

The company also signed an exclusive global distribution agreement for the Xtract catheter with interventional device manufacturer Lumen Biomedical in May 2009, Volcano has acquired the entire Xtract Thrombus Aspiration Catheter device line.

The acquisition will allow for the building of the company’s portfolio of diagnostic and therapeutic tools to help patients with coronary artery disease at all levels of complexity, including acute myocardial infarction, said Volcano.